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Featured Whitepaper: Vaisala
GMP Warehouse Mapping
Sponsored By: Vaisala
Vaisala recommends a nine-point process for successful mapping of a GxP-compliant warehouse or storage space. These nine steps will ensure that you take into consideration the most important elements of validation, especially understanding where temperature and humidity pose risks to product quality.
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Managing the Complexities of Global Pharmaceutical Sourcing
Author: DPT Laboratories
With the increased globalization and complexity of the pharmaceutical supply chain, managing the sourcing of materials has become extremely challenging. Reducing time and costs are important goals of sourcing, but increased regulations and more rigorous enforcement make these goals difficult to achieve. These trends have forced life science industry companies to optimize sourcing activities for raw materials, intermediates, active pharmaceutical ingredients (APIs), and other material components for clinical supplies and commercial manufacturing. Download this white paper to learn more. |
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Using Quality By Design To Improve Strength, Friability
Authors: Joe Cobb, R. Justin Brett, Michael D. Ruff, Anthony Berry, Robert Epps
Sponsored By: Metrics, Inc.
Using Quality By Design principles, Metrics Inc. scientists improved the friability and increased the strength of a core tablet destined for modified release dosage form. |
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The Utility of ITS2 Sequencing for Identifying Fungal Contaminants
Author: Charles River
In the past decade, the pharmaceutical manufacturing industry has witnessed prononunced growth, accompanied by an increase in oversight and new manufacturing regulations. Industrial settings today are also faced with pronounced prevalence of molds, a situation that can lead to environmental monitoring excursions and suspension of operations. Interestingly, recalls due to fungal contamination are also on the rise. |
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Are You Prepared for New Elemental Impurities Guidelines?
Author: Jim Janeen Skutnik
Sponsored By: NSF-DBA, part of NSF Health Sciences
The pharmaceutical industry is facing great uncertainty about new elemental impurities guidelines from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). These guidelines are currently being developed and have recently reached consensus agreement and will be submitted for public consultation. Even those of us involved in the crafting of the new guidelines know significant changes are coming, but we won't know every detail of the changes until after the ICH approves and publishes the new guidelines. In line with ICH, we also have to contend with revisions to United States Pharmacopeia (USP) General Chapters and approach to elemental impurities. So what do we do until then? |
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OPC: The Ins and Outs to What It's About
Author: Darek Kominek
Sponsored By: Matrikon OPC
The Every Man's Guide to OPC is an easy-to-read overview of the most popular industrial open connectivity standard, OPC. This paper first introduces the main idea behind OPC, shows why OPC is different from conventional (often proprietary) communication protocols, and explains how OPC helps overcome the limitations of such native protocols. |
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Establishing a Culture of Quality
Author: Ron Johnson, President, Becker & Associates Consulting
Sponsored By: NSF Becker
For companies seeking to prevent or remediate regulatory compliance violations, establishing a culture of quality is of the essence. In industries strongly affected by regulatory compliance, product quality is inextricably linked to a company’s well-being. Learn more about cultivating and nourishing a culture of quality in your firm. |
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Melt Extrusion – Shaping Dosage Forms in the 21st Century
Authors: Charlie Martin; Feng Zhang, PhD; James C. DiNunzio, PhD
Sponsored By: Leistritz
Melt extrusion has been an established industrial manufacturing technology for more than 50 years. It is only in the last decade or so that it has emerged as a viable platform for pharmaceutical development. Today, applications of melt extrusion range from controlled release systems to oral bioavailability enhancement and show potential for small molecules and therapeutic peptides. |
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Implementing Disposable Cleanroom Apparel into the Manufacturing Process
Author: Damon Larking
Sponsored By: Kimberly-Clark Professional
This paper addresses the benefits of disposable cleanroom apparel versus reusable apparel. It explains how disposable cleanroom apparel can help play a role in helping pharmaceutical manufacturers reduce their waste stream while reducing the risk of contamination. |
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Tablet Design: How to Mitigate Medication Error and Threats to Patient Safety
Authors: Jay Anbil, Steve Yoder
Sponsored By: Colorcon
Medical prescription drug errors by doctors, pharmacists, and patients account for 1.5 million incidences of sickness, injuries, or deaths in the U.S. each year. Thirty percent of these unnecessary adverse events are attributed to human errors in identifying drugs and dosages. In fact, more people die from adverse drug events each year than from highway accidents, breast cancer, or complications from HIV. Learn how proper tablet design plays a crucial role in differentiating drug products and can mitigate the risk of medication errors. |
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Mitigating Supply-Chain Risk through Supplier Quality Agreements
Author: ETQ
Outsourcing is on the rise, especially in the Pharmaceutical and Life Sciences industry. However, with all the benefits to outsourcing, we open ourselves up to a higher risk level. Learn what these risks are, and how many pharmaceutical companies are implementing a Supplier Quality Agreement to help mitigate some of these risks. |
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Analysis for Polysorbate 80 Using New High Performance Liquid Chromatography (HPLC) Method with Charged Aerosol Detection (CAD)
Author: Lindsay L. McNalley
Sponsored By: Impact Analytical
Polysorbate 80 (polyoxyethylene (20) sorbitan monooleate) is a common nonionic surfactant, emulsifier and solubilizer that is used in a wide variety of industries and applications. Polysorbate 80 is typically used in food products, cosmetics, medications, vitamins, and vaccines. There can be many reasons a company may need to determine the exact amount of polysorbates in their material. For example, companies may need to determine AIG limits in their products, validate analytical methods for product production, or require the information for reverse engineering purposes. Thus, a well-developed analytical method is crucial for accurately quantitating polysorbates. |
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